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Since Galician virgin olive oils have a high content of bioactive phenolic compounds and these are attributed to a large part of the healthy properties of the Mediterranean Diet, our starting hypothesis is that these olive oils could attenuate insulin resistance, improving glycemic control in terms of fasting plasma glucose and/or glycated hemoglobin and insulin sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | For 24 weeks, subjects in this arm will have their diet supplemented, daily, with an amount of 30 ml of EVOO (Extra Virgin Olive Oil). Subjects in this arm will also receive qualitative dietary recommendations for following a healthy diet from the nutritional recommendations for patients with diabetes (Evert et al. (2013). Diabetes Care, 36 (11), 3821-3842.). |
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| Control arm | No Intervention | Subjects in this arm will receive qualitative dietary recommendations for following a healthy diet from the nutritional recommendations for patients with diabetes (Evert et al. (2013). Diabetes Care, 36 (11), 3821-3842.). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVOO diet supplement | Dietary Supplement | For 24 weeks, subjects in intervention arm will have their diet supplemented, daily, with an amount of 30 ml of EVOO (Extra Virgin Olive Oil). |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | At baseline, at 12 weeks and at 24 weeks | |
| Fasting plasma glucose (FPG) | mg/dl | At baseline, at 12 weeks and at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Years | Baseline |
| Sex at birth | Male/female | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beatriz Cancho Grande | Ourense | 32004 | Spain |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Cardiovascular Risk Factors |
Cardiovascular risk factors from the following list will be indicated: Arterial hypertension: Yes/No Dyslipidemia: Yes/No Smoking: Non-smoker Current smoker Recent ex-smoker (<1year) Former smoker (≥1year) |
| Baseline |
| Hepatic dysfunction | Yes/No | Baseline |
| Previous heart disease | Yes/No | Baseline |
| Heart failure | Yes/No | Baseline |
| Coronary Heart Disease | Yes/No If yes, answer the following questions:
| Baseline |
| Concomitant pharmacological treatment | The concomitant pharmacological treatment will be indicated by marking the appropriate one in the following list: Diuretics: Yes/No Mineralcorticoid receptor antagonists: Yes/No ACE inhibitors: Yes/No ARBs2: Yes/No Sacubitril/Valsartan: Yes/No Ivabradin: Yes/No Statins: Yes/No AntiPCSK9: Yes/No Ezetimibe: Yes/No Fibrates: Yes/No Antiaggregants: Yes/No Anticoagulants: Yes/No Beta-blockers: Yes/No Calcium antagonists: Yes/No Antiarrhythmics: Yes/No | Baseline |
| Antidiabetic treatment | Antidiabetic treatment: Yes/No If Yes, will indicate which of the following list: Metformin: Yes/No Sulfonylurea: Yes/No I-DPP4: Yes/No I-SGLT2: Yes/No ArGLP1: Yes/No Pioglitazone: Yes/No Insulin: Yes/No If insulin is "Yes", which type of dose from the following list will be indicated: Basal (1); Two-dose NPH or premixes (2); Basal-bolus (3); Total daily dose: IU/day | Baseline |
| Systolic Blood Pressure | mm Hg | At baseline, at 12 weeks and at 24 weeks |
| Diastolic blood pressure | mm Hg | At baseline, at 12 weeks and at 24 weeks |
| Heart rate | beats/minute | At baseline, at 12 weeks and at 24 weeks |
| Weight | kg | At baseline, at 12 weeks and at 24 weeks |
| Heigth | cm | Baseline |
| Body Mass Index (BMI) | kg/m2 | Baseline |
| Urinary albumin excretion (UAE) | mg/24 h | At baseline, at 12 weeks and at 24 weeks |
| Estimated Average Plasma Glucose | mg/dl | At baseline, at 12 weeks and at 24 weeks |
| Fasting Insulin | µU/ml | At baseline, at 12 weeks and at 24 weeks |
| Homeostatic Model Assessment for beta-cell function (HOMA-B) | At baseline, at 12 weeks and at 24 weeks |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Adimensional | At baseline, at 12 weeks and at 24 weeks |
| N-terminal pro-B-type natriuretic peptide (NT-proBNP) | pg/ml | At baseline, at 12 weeks and at 24 weeks |
| Total cholesterol | mg/dl | At baseline, at 12 weeks and at 24 weeks |
| LDL-C HDL-C, mmol/l | mg/dl | At baseline, at 12 weeks and at 24 weeks |
| HDL-C | mg/dl | At baseline, at 12 weeks and at 24 weeks |
| Triglycerides (TG) | mg/dl | At baseline, at 12 weeks and at 24 weeks |
| Dietetic education | Visit with Dietitian: Yes/No | At baseline, at 12 weeks and at 24 weeks |
| Cardiovascular events | It will be indicated if cardiovascular events have occurred: Yes/No | At 12 weeks and at 24 weeks |
| D004700 | Endocrine System Diseases |